LONGEVITY 1NCT06268132
Longevity in Russia
An observational study of LONGEVITY 1 and Frailty, run by Center for Strategic Planning, of the Federal Medical and Biological Agency at 1 site in Russia.
Trial summary
This is an observational cohort study of long-living adults (participants aged 90 and above) from the Central Federal District of Russia. The study seeks to determine the genetic and cellular and molecular determinants of healthy longevity and to assess the impact of lifestyle and socioeconomic and environmental… Read more about this study
- Who is it for?
- Ages 90 years and older
- Conditions the study is for
- LONGEVITY 1, Frailty, Aging
- How many people
- 4,000 participants
- Where
- 1 siteRussia
- Study dates
- 25 Dec 2019to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 90 years and older
- All sexes
- Older adult
Study population: The inclusion of participants will be carried out with the involvement of social services, boarding houses for labor veterans, geriatric centers and other geriatric services in the central region of Russia
Who may be able to join
- Informed consent
- 90 years of age or above
Who cannot join
- Refusal to participate or to provide informed consent;
- Any other criteria deemed reasons for exclusion by the Principal Investigator.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
RUSSIAN CLINICAL AND RESEARCH CENTER OF GERONTOLOGY, Pirogov Russian National Research Medical University of the Ministry of Healthcare of the Russian Federation
Moscow, 129226
Irina D. Strazhesko, M.D., Ph.D, +7 (499) 187-64-67, Istrazhesko@gmail.com
About this study
Official title: Healthy Longevity and Mortality in Long-living Adults: Contributors and Causes - Lifestyle, Socioeconomic Background, and Replicative Aging
This is an observational cohort study of long-living adults (participants aged 90 and above) from the Central Federal District of Russia.
The study seeks to determine the genetic and cellular and molecular determinants of healthy longevity and to assess the impact of lifestyle and socioeconomic and environmental factors on healthy longevity.
The study is expected to result in the development of a panel of markers of healthy longevity and/or a model of healthy aging based on the analysis of all factors under consideration.
Read the detailed description
The study involves a long-term observation of a cohort of long-living adults. During the first visit, a medical professional will take a detailed medical history and perform a comprehensive geriatric assessment (for 15 geriatric syndromes), and physical examination. The participants will have their biomaterials sampled for basic and extended blood biochemistry testing, telomere length measurement, common urine tests and subsequent biobanking and additional studies: whole genome sequencing, DNA methylation analysis, transcriptome analysis, and 16S RNA sequencing of stool and saliva.
Follow-up checks will be carried out once a year by phone or during additional visits.
The study seeks to identify the genetic, epigenetic, and metagenomic determinants associated with the successful and unsuccessful aging phenotypes, mortality, and survival in long-living individuals.
- Conditions
- LONGEVITY 1, Frailty, Aging, Age-related Cognitive Decline, Aging Disorder
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Long-living individuals | Long-living individuals at least 90 years of age from the Central Federal District of Russia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality among long-living adults
Mortality among long-living adults within at least 1 year after inclusion in the study and factors associated with mortality will be assessed.
Measured: at least 1 year after inclusion in the study
Morbidity among long-living adults
Morbidity among long-living adults within at least 1 year after inclusion in the study and factors associated with morbidity will be assessed.
Measured: at least 1 year after inclusion in the study
Secondary outcomes (5)
Aging phenotypes
Identification of successful and unsuccessful aging phenotypes
Measured: at least 2 years after inclusion in the study
Social, economic, and medical- history-related determinants
Identification of social, economic, and medical- history-related determinants of successful and unsuccessful aging, geriatric syndromes
Measured: at least 2 years after inclusion in the study
Genetic determinants
Identification of the genetic determinants of successful and unsuccessful aging, geriatric syndromes
Measured: at least 2 years after inclusion in the study
Epigenetic determinants
Identification of the epigenetic determinants (methylation sites) of successful and unsuccessful aging, geriatric syndromes
Measured: at least 2 years after inclusion in the study
Metagenomic determinants
Identification of the metagenomic determinants (16S-rSeq) of successful and unsuccessful aging, geriatric syndromes
Measured: at least 2 years after inclusion in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start25 Dec 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LONGEVITY 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Strategic Planning, of the Federal Medical and Biological Agency
- Sponsor type
- University, hospital or other
- Collaborators
- Pirogov Russian National Research Medical University
- Responsible party
- Sponsor
- Investigators
- Irina D. Strazhesko, M.D., Ph.D, Principal investigator, Pirogov Russian National Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268132
- Sponsor's protocol ID
- MLS90
- Status last verified
- Feb 2024
- First submitted
- 13 Feb 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Longevity and Mortality in Long-living Adults: Contributors and Causes - Lifestyle, Socioeconomic Background, and Replicative Aging
- ClinicalTrials.gov ID
- NCT06268132
- Acronym / sponsor ID
- MLS90
- Conditions
- LONGEVITY 1, Frailty, Aging, Age-related Cognitive Decline, Aging Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Center for Strategic Planning, of the Federal Medical and Biological AgencyUniversity, hospital or other
- Collaborators
- Pirogov Russian National Research Medical University
- Study start
- 25 Dec 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational cohort study of long-living adults (participants aged 90 and above) from the Central Federal District of Russia.
The study seeks to determine the genetic and cellular and molecular determinants of healthy longevity and to assess the impact of lifestyle and socioeconomic and environmental factors on healthy longevity.
The study is expected to result in the development of a panel of markers of healthy longevity and/or a model of healthy aging based on the analysis of all factors under consideration.
Detailed description
The study involves a long-term observation of a cohort of long-living adults. During the first visit, a medical professional will take a detailed medical history and perform a comprehensive geriatric assessment (for 15 geriatric syndromes), and physical examination. The participants will have their biomaterials sampled for basic and extended blood biochemistry testing, telomere length measurement, common urine tests and subsequent biobanking and additional studies: whole genome sequencing, DNA methylation analysis, transcriptome analysis, and 16S RNA sequencing of stool and saliva.
Follow-up checks will be carried out once a year by phone or during additional visits.
The study seeks to identify the genetic, epigenetic, and metagenomic determinants associated with the successful and unsuccessful aging phenotypes, mortality, and survival in long-living individuals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long-living individuals | – | –Long-living individuals at least 90 years of age from the Central Federal District of Russia |
Who may qualify
- Ages
- 90 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- The inclusion of participants will be carried out with the involvement of social services, boarding houses for labor veterans, geriatric centers and other geriatric services in the central region of Russia
Key inclusion criteria (2 listed)
- Informed consent
- 90 years of age or above
Key exclusion criteria (2 listed)
- Refusal to participate or to provide informed consent;
- Any other criteria deemed reasons for exclusion by the Principal Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality among long-living adults
Time frame: at least 1 year after inclusion in the study
Mortality among long-living adults within at least 1 year after inclusion in the study and factors associated with mortality will be assessed.
Morbidity among long-living adults
Time frame: at least 1 year after inclusion in the study
Morbidity among long-living adults within at least 1 year after inclusion in the study and factors associated with morbidity will be assessed.
5 secondary outcomes
Aging phenotypes
Time frame: at least 2 years after inclusion in the study
Social, economic, and medical- history-related determinants
Time frame: at least 2 years after inclusion in the study
Genetic determinants
Time frame: at least 2 years after inclusion in the study
Epigenetic determinants
Time frame: at least 2 years after inclusion in the study
Metagenomic determinants
Time frame: at least 2 years after inclusion in the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irina D. Strazhesko, M.D., Ph.D principal investigator
Pirogov Russian National Research Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of LONGEVITY 1 and Frailty, run by Center for Strategic Planning, of the Federal Medical and Biological Agency at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daria A. Kashtanova, M.D., Ph.D (+74955406171 ext. 4120, DKashtanova@cspfmba.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality among long-living adults (time frame: at least 1 year after inclusion in the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.